Biotech Debacle in Four Parts

Share in the top biotech firms have dropped 43 percent since January 2002. BioCentury, the industry newsletter in San Carlos, California, listed 61 public firms (out of 494 companies worldwide) that had a year or less worth of cash on their balance sheets at the end of the first quarter of 2002.

In the East Bay alone, 18 biotech companies lost $7.5 billion in market capitalization - about 38 percent of their value - since the middle of January. Many firms have had half of their value evaporate. Several Seattle-area companies have joined the club.

Biotech companies raised $19.9 billion through worldwide stock offerings in 2000 and about one-quarter that sum in 2001. This year, however, biotechs have raised only $843 million from stock offerings, which, if the trend continues, would amount to less than one-tenth of the amount raised two years earlier.

Well over 1,000 companies have been formed in the past 20 years and only a handful have become powerhouses - the industry has been considered too risky for loans or even junk bonds. Instead, biotechs are dependent on venture capitalists, enthusiastic stock-market investors and large pharmaceutical companies that need new drugs to keep growing.

The Nasdaq Biotech Index has consistently performed worse than the languishing Dow. Falling stock prices hit 52-week lows in July for firms including Chiron Corp. and Abgenix Inc. Not even Pfizer s $60 billion purchase of Pharmacia pumped enthusiasm into the market.

Most companies are still reporting double-digit losses and profitability remains years away.

There was also a string of recent drug failures. Abgenix, Protein Design Labs, Xoma LLC and Chiron all delayed or cancelled drug development plans after poor drug trial results late last year and this year. The FDA in late December refused to accept ImClones application for its once-promising cancer drug Erbitux, setting off waves of scandals. Former ImClone CEO Sam Waksal was arrested on charges of insider trading after recommending that friends and family sell stock ahead of the Erbitux rejection.

Genomic-tool and -technology companies have laid off at least 1,500 people worldwide since the sector began its slide in the fall of 2000. Investors lost confidence in these firms ability to maintain growth as pure-play providers of tools or data.

The number is an underestimate, as private companies, unlike public companies, are not required by law to disclose wholesale layoffs. The list of more than 20 companies announcing lay-offs include such high profile companies as Incyte, which fired about 400 staff in November 2001, and Celera Genomics, which fired 132 in June 2002, after its CEO and human genome sequencer Craig Venter departed in January.

Bayer, the troubled German chemicals and pharmaceuticals conglomerate, have been making repeated job cuts since the beginning of this year.

Business at the group has fallen in all its units and Bayer faces up to 2,000 lawsuits over Baycol, the cholesterol-lowering drug linked to 100 deaths. Manufacturing problems have hit sales of Kogenate, another key product, and the launch of a new impotence pill has been delayed by regulators who want more safety data.

In September 2002, Bayer announced 4,700 more job cuts, or 3.7% of its global work force, by 2005. These latest job cuts come hot on the heels of the 10,300 cuts over the next four years previously reported.

Biotech giant Syngenta is ending a three year collaboration with UKs John Innes Centre (JIC). This will include abandoning the Syngenta laboratory, part of a new Genome Centre complex on the site completed just eight months ago, at tax-payers expense.

The company is also ending its involvement with the Sainsbury laboratory, which has a world reputation for research in molecular plant pathology and genetics.

"The decision brings to an end what was seen as a new model for getting public-funded research into the private sector", commented Farmers Weekly.

Syngenta, which had sales in 2001 of around US $6.3 billion (£4 billion), employs more than 20,000 people in over 50 countries, and has a staff of 14 at JIC. The company was formed by the merger in 2000 of Novartis and AstraZeneca, which set up the JIC collaboration in 1999.

"We will continue to work to use the knowledge gained from our mapping of the rice genome to generate commercially-viable products in the cereals sector," said the statement released 18 September, "It is the need to simplify our R&D organisation, to rationalise a global network of R&D sites, and to remove overlap in research capabilities that has led to this decision."

Shares of agbiotech company Monsanto fell to a 52-week low in July before recovering, after its parent Pharmacia Corp. agreed to be acquired by industry leader Pfizer Inc on condition that Monsanto is to be spun off. Pharmacia distributed their 87% of the shares in Monsanto to their shareholders in August.

Monsanto Company earnings for the second quarter of 2002 were down on bad debt. The company reported net income of 56 cents per share, which includes the Argentine bad-debt reserve of $100 million after tax (38 cents per share) and restructuring charges of $43 million after tax (16 cents per share).

Monsanto also had to write off $2 billion of goodwill, ie, the money they paid to buy up Argentine and Brazilian seed companies which was translated into assets on their balance sheet. The South American companies are now worthless and have to be written down in the accounts.

At the end of July, the company announced that they were backing off indefinitely from plans to commercialize herbicide-resistant Roundup Ready wheat, the most important new crop in the biotech pipeline. Monsanto had promised that the first GE wheat would hit the market in 2003, but earlier this year, they pushed the date back to 2005.

Monsantos GM wheat joins the growing list of failed and abandoned GM crops: the Flavr Savr tomato and the Endless Summer tomato, both in 1996; Bt potatoes and GM flax GE flax in 2001; herbicide-resistant sugar beets and StarLink corn in 2000. Other crops such as GM rice have been put on indefinite hold. Monsantos controversial recombinant Bovine Growth Hormone (rBGH) has been banned in every major industrialized nation except for the US, Mexico, and Brazil.

Recombinant pig growth hormone (rPGH) has been approved in only one industrialized nation, Australia. Other biotech crops, including squash and zucchini, are grown by so few farmers that it's difficult to determine if they are even commercially available.

The company tried to raise $650m from the commercial debt markets but was only able to borrow $163.390m. It also faces falling sales of its traditional herbicide Roundup after the patent expired in the US. Roundup accounts for 45% of Monsanto revenues.

Monsanto now admits it will take at least another three years before winning approval for their sale in Europe. It is working on the assumption that it will make no progress in Europe until 2005.

Monsanto also expects a lack of progress in Brazil, a key producer of soya beans, which has managed to resist pressure from Washington to grow GM crops, until 2005.

BioDemocracy News 40: The Death of Frankenfoods, August 2002, by Ronnie Cummins, Organic Consumers Association www.organicconsumers.org

"Troubled Monsanto scales down GM hope in Europe" by David Teather, 20 August 2002, The Guardian

Singapores biotech a non-starter

Singapores government sees medical research as a key to its economic survival. Still recovering from its worst recession since 1964, the city-state is pumping a lot of money into the life sciences, importing talent and building complexes to focus activity. But that has failed to impress the private sector.

Singapore has pledged at least S$3 billion ($1.7 billion) in the last two years to build infrastructure, train scientists and fund research and start-ups. Its spending spree coincided with the slide of share prices in U.S. biotech firms.

"Singapore investors have shied away from biotech only because it s been too risky", said Christina Lim, head of Vertex Managements biotech investments, representing the venture capitalists.

2. Recent Evidence of Genetic Biohazards

Massive failures of Bt cotton crops in India

Illegally planted Bt cotton crops have failed catastrophically in several states in India.

In the Khargone district of Madhya Pradesh, which is facing a severe drought, Bt cotton crops have failed 100%. Farmers are demanding a compensation of Rs. 5000 million or they would take legal action against the Government of Maharashtra and Monsanto-Mahyco for allowing the sale of inadequately tested GM seeds.

While other non-GM cotton varieties have also been adversely affected by the drought, the failure rate is only around 20%.

In the Vidarbha cotton belt in the adjoining state of Maharashtra, more than 30,000 hectares have been damaged by root rot, with over 70% of crop areas affected. Many farmers recorded poor seed germination, some only up to 50%. They are also demanding a compensatory package of Rs 5,000 million.

Preliminary reports from the North zone indicate was that the Bt cotton crop has been performing well, but cotton scientists said it was found susceptible to the leaf curl virus in about 5 to 10% of the area.

Bt cotton crops in the Bhavanagar Surendranagar and Rajkot district of Gujarat were attacked by bollworm, despite being initially resistant in the early phases of plant growth. It has also been found that Gujarat is growing 18,000 hectares of the Bt. cotton more than the permitted 12,000 hectares by the Government of India.

This finding was amply confirmed in an experimental plot in Anandwan College of Agriculture, affiliated to Dr. Panjabrao Deshmukh Agricultural University. The American bollworm had devastated 80% of the crop. The Dean of the College, Dr. M Y Palarpawar cried foul. "Here, Bt cotton has proved to be a hoax," he said.

ISIS has warned of this possibility, not only from gene therapy, but also from other exposures to transgenic DNA, as from GM food. The artificial GM constructs used are similar in both cases.

The French team that made news in 2000 treating children with severe combined immune deficiency (SCID) had to call a halt to the gene therapy trial. One of the ten children treated developed leukaemia.

SCID is attributed to a mutation in a gene on the X-chromosome. Alain Fischer and Marina Cavezzena-Calvo at the Necker Hospital in Paris pioneered the ex vivo procedure, in which bone marrow cells taken from the patient are transformed outside the body, using a vector carrying a normal copy of the mutated gene to insert the gene into the genome. The transgenic cells are then re-introduced into the patient.

This was hailed as a breakthrough for gene therapy, as it avoided most of the risks of in vivo treatments in which the transgenes are directly introduced into the patient, which put patients at immediate risks from toxicities of the vector that killed teenager Gelsinger in 1999. In addition, infectious viruses could be generated from the vector, and cancer could result from the insertion of the vector into the wrong places in the genome. As in the genetic modification of plants and animals, the genetic modification of human beings is severely hampered, to a large extent, because precisely targeted gene insertion is still not technically feasible. It is hoped that by modifying the cells outside the patients body, the patient will not be directly exposed to high doses of the vector, and any cells that develop cancer, or any infectious viruses that are generated could be selected out.

But, a routine check of one patient last Spring revealed that the child had a high number of T cells in his blood, and by August, the T cell count reached 200 000 cells per litre. The child was admitted to hospital.

Molecular analysis showed that the T cells were a clone derived from one original cell that has multiplied out of control. The retroviral vector used  mouse Moloney leukaemia virus  had jumped into a gene on chromosome 11 that is over-expressed in a form of acute leukaemia. An additional anomaly in these T cells was that part of chromosome 6 was duplicated and attached to chromosome 13.These are typical signs of transgenic instability.

It is a difficult choice when one is faced with a life-threatening condition that appears to be successfully treated by a procedure that so far, seems to carry a risk small enough to be worth taking.

But farm workers and members of the general public, who are not suffering from life-threatening conditions, are nevertheless exposed to the potential risks of transgenic DNA from eating GM foods and from other sources such as GM pollen.

We need is a comprehensive review not just of gene therapy, but also of other transgenic technologies that expose people to transgenic DNA,such as genetic modification of animals and plants for other biomedical and agricultural applications. The methods and constructs used are similar, and so are the risksinvolved.

Sources:

Science, News of the Week, 4 October 2002.

"What to do when clear success comes with an unclear risk?" Science 2002, 298, 510-1.

Many biotechnology drugs are promoted on grounds that they are"the bodys own solutions".

But an outbreak of serious illnesses linked to the anemia drug Eprex shows that some patients do not react to genetically engineered proteins as if they were natural. Instead, the patients react as if the protein is foreign, and their immune systems try to destroy it.

Eprex, made by Johnson & Johnson and sold only outside the United States, is widely believed to be responsible for 141 cases of pure red cell aplasia, in which the body is unable to produce red blood cells, making some patients dependent on transfusions to survive.

It is now clear that virtually all biotech drugs provoke immune responses in some patients, though usually just tiny fractions. But these add up as the number of protein drugs increases.

Patients can experience allergic reactions or even potentially fatal shocks. In most cases, the body makes antibodies that attack the protein, rendering it less effective.

Up to one-third of haemophiliacs develop immune reactions to the blood-clotting protein Factor VIII. In desperation, some undergo yearlong treatments at a cost of $1 million to try to restore the drugs usefulness.

Between 5 to 40 percent of multiple sclerosis patients develop resistance to beta interferon, according to Dr. Richard A. Rudick, director of the Edward J. and Louise E. Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic. Although there is debate about whether the presence of the antibodies is important, Dr. Rudick said, many such patients are unlikely to benefit from the drug.

What makes the illnesses associated with Eprex more alarming is that the antibodies produced by the patients not only make the drug ineffective, they also attack the patients own protein. So the patients can no longer produce any red blood cells, ending up with worse anemia than they would have had without the drug.

The reasons for the immune responses are not clear. Putting the human gene for the protein into bacteria or animal cells could result in proteins subtly different from the natural protein, in the sugars attached to the protein, or in the way they are folded. In other cases, the drug may have an impurity.

The factory in Puerto Rico, which makes Eprex, is under criminal investigation. The same protein, sold in the United States as Procrit by Johnson & Johnson and as Epogen by Amgen, is linked to just a handful of cases of red cell aplasia. Amgen, which developed the drug, makes both brands in a factory in Colorado.

Another problem, experts say, is that biotech drugs made by living cells is not as predictable as those made chemically. (This recalls the epidemic linked to a batch of genetically engineered tryptophan in the United States in 1989.)

The 141 suspected cases of red cell aplasia should be seen against the background of the three million people who have been treated with Eprex or its American counterparts for more than 10 years. Many of those patients are able to work or lead more normal lives because the drug eliminates the fatigue of anemia.

The drug is a form of erythropoietin, a protein produced by the body to spur the production of red blood cells, which ferry oxygen around the body. It is normally produced by the kidney and is widely given to people with kidney disease and are on dialysis machines.

Human insulin made by genetic engineering supplanted insulin from animals.
The human version generally provokes far fewer immune reactions and lets diabetics control their insulin better. Nevertheless, a small percentage of diabetics say they cannot tolerate the human version and are trying to keep cow and pig insulin available.

The Eprex problem is something of a black eye for what has been the biotechnology industrys most successful product. Eprex and its American cousins exceed $5 billion in combined yearly sales. But, ironically, it could help in the long run, by eliminating generic competition.

For drugs made chemically, generic manufacturers do not have to run expensive clinical trials. They need to show just that their drug is identical to the brand-name product. But the biotechnology industry and the FDA have said, "it is too difficult to show that two biotech drugs are equivalent without full clinical trials".

This actually sums up the generic nature of hazards in gene drugs, and the impossibility of quality control, and should make regulators and the general public more wary.

Sources:

"Rebellious Bodies Dim the Glow of 'Natural' Biotech Drugs" by Andrew Pollack, 30 July 2002, New York Times

When a scientist in Jena, Germany reported that transgenic DNA in pollen has transferred to bacteria and yeast in the gut of bee larvae, it was dismissed. The paper was submitted to and rejected from Nature, and never heard of again.

Now, scientists in University of Newcastle upon Tyne have found that bacteria in the human gut can take up DNA from GM food. But the UKs Food Standards Agency, which commissioned the research, is reported to have said, "the overall findings are reassuring rather than alarming because the amount taken up was barely detectable and only occurred in special circumstances".

Harry Gilbert and colleagues at the University of Newcastle upon Tyne made the discovery, after feeding volunteers with a burger and a milk shake containing GM soya. Twelve healthy volunteers were tested in addition to seven whose colons and lower small intestine had been surgically removed, and were carrying ileostomy bags.

The researchers examined the stools from the healthy volunteers and found no trace of the transgenic DNA. But in the wastes from the seven ileostomy bags, they found that up to 3.7 % of the transgenic DNA had survived, and in three of the seven, the gut bacteria had taken up the DNA, though the actual strains of bacteria could not be isolated. They speculated that people with ileostomy might produce less of the enzyme that degrades DNA, thus accounting for the different findings.

In a separate experiment on colonies of intestinal cells, Gilberts team showed that loops of GM DNA called plasmids can be taken up directly, but only by one gut cell in 3000.

"These data support the view that GM soya does not represent a significant risk to human health through gene transfer," says the Gilbert team.

But Dr. Mae-Wan Ho, who reviewed the report, said that the design of the experiment was already heavily biased against finding positive results, such as using a probe for GM DNA that detects only 5% of the entire length, and hence the extent of transfer of transgenic DNA is likely to be much more extensive.

Furthermore, she criticised the scientists for not monitoring the blood of the volunteers. In experiments dating back to the early 1990s, German scientists have found that transgenic DNA fed to mice can pass through the gut and also through the gut wall into the blood stream, ending up in blood cells, liver and spleen cells. "The fact that all the transgenic DNA has disappeared from the faeces of the healthy volunteers could mean that it has all been absorbed into the bloodstream." She said.

Scientists from three universities studied GM sunflowers with a gene from the soil bacterium Bacillus thuringiensis that produces a chemical toxic to certain insects to see what happened when these foreign genes were inadvertently passed along to weedy relatives.

This gene has been incorporated into a number of commercial crops, including corn, cotton and soybeans, to help the plants repel moths and butterflies, whose larvae are prime pests of growing crops.

The researchers crossed cultivated sunflowers containing the Bt transgene with wild, sunflowers. The experimental populations were grown at two sites: an open, pasture like area in Nebraska and an intensely cultivated area in Colorado.

The second generation of wild sunflowers contained the transgene, showing that the alien gene could be transferred. The wild Bt sunflowers had 50 percent more seeds than control hybrids without the gene. These plants also had far less insect damage, suggesting that that the insecticidal gene was working in preventing insects from eating the plant.

The researchers also found that the addition of the Bt gene did not harm the weeds physical fitness, even when the sunflowers were deprived of water and nutrients to mimic drought conditions.

In many crop species grown commercially in the U.S., wild relatives will readily crossbreed with crops growing nearby. This happens for more than 20 species in the United States, including sunflowers, sorghum, carrots, radishes, rice and turf grasses.

Many genetically modified cultivated crops could potentially crossbreed with weeds, said Allison Snow, one of the researchers. "Weeds are already hardy plants; the addition of transgenes could just make them tougher."

Snow conducted the study with researchers from the University of Nebraska and Indiana University. The team presented their findings August 8 at the annual meeting of the Ecological Society of America in Tucson.
Source: "Engineered Genes Help Wild Weeds Thrive", by Cat Lazaroff, Environmental News Service, Washington, USA. 9 August 2002.

Glyphosate-resistant weed plagues GM field in West Tennessee

Glyphosate-resistant marestail infested over 200,000 acres of cotton in west Tennessee this year, 36 percent of all cotton acreage in the state, say University of Tennessee weed scientists.

Glyphosate-resistant marestail was also a problem on around 200,000 acres of soybeans, according to Neil Rhodes, Extension weed control specialist with UT. Rhodes and Bob Hayes, professor of weed science with the University's West Tennessee Experiment Station.

The first incidence of the glyphosate-resistant marestail, which is also called horseweed, occurred in 1999, according to Rhodes. "We began to get reports of non-performance in Lauderdale County in west Tennessee. The complaints have increased over the years."

Last year, Bob Hayes officially confirmed glyphosate- resistant marestail in west Tennessee. "This year, we have gotten reports just about everywhere we have cotton," Rhodes said. "Unfortunately, it has spread quite rapidly."

UK Farm Scale Field Trials fiascoThe wrong seeds were planted at 14 sites, the Government has admitted. The tests had been contaminated for the past three years by seeds containing different genes from the ones approved.

More than two per cent of the seeds used in the trials contained an antibiotic resistance marker gene thats not supposed to be there.

This falls planting was suspended for more than 2 weeks because of the fiasco.

Elliot Morley, the Food Minister who recently called for a public debate on the future of GM foods, admitted that the credibility of the GM trials had been damaged.
Ministers said that the mix-up, which occurred during the seed production process, did not make the experiments invalid.

However, Mr Morley admitted the failure was a significant one and said the Government was considering legal action against Aventis, the biotech company responsible.

Scimac, the industry body that co-ordinates the farm scale trials, said that the breach of regulations was regrettable but that the trials should still be continued.

It was an agricultural college in Scotland that discovered the GM crops it planted for Aventis were contaminated by another strain of GM seeds, which had an antibiotic-resistance gene. Subsequent tests on other sites found that a total of twelve in England and two in Scotland were also contaminated with the antibiotic-resistant GM.

Aventis said that it had mistakenly used an old batch of seeds, "which were meant to contain 3 per cent of the antibiotic-resistant seeds". Or could it be that the transgenic line was never uniform in the first place? What concerns food campaigners is that the contaminated trials went on for three years across the country before they were discovered.

Many scientists have expressed concern that the gene may leak out into the environment, and particularly to bacteria. This could make the bacteria resistant to antibiotics and so make it difficult for doctors to treat infections.

Biotech companies reportedly said "there is virtually no chance of that because it is almost impossible for a gene to transfer from a plant to a bacteria except under laboratory conditions", which is untrue, as there is evidence this has occurred in the field. They also said that although the gene is active in plants, it becomes far less active when inserted into bacteria. This is also untrue, because the cauliflower mosaic virus promoter, used with many transgenes including antibiotic resistance marker genes, is active in bacteria. Then they claim that the antiobiotics to which it gives resistance are not used in the UK. This is again untrue.

The gene is reported to confer resistance to kanamycin, an aminoglycoside antibiotic, and is known to give cross-resistance to newer antibiotics in the same chemical family, such as streptomycin, gentamycin and tobramycin that are definitely in use. Regulators in the US and elsewhere have approved kanamycin resistance gene in GM crops on grounds that kanamycin is no longer used. They were mistaken. Kanamycin is used prior to endoscopy, to treat ocular infections. It is also used in blunt trauma emergency treatment and has been found to be effective against E. coli 0157.

Federal regulators decision to investigate two biotechnology companies corn crops in Hawaii puts the state in a worldwide debate on the safety and desirability of genetically modified crops.

The Environmental Protection Agency (EPA) said yesterday that the companies, Mycogen on Molokai and Pioneer Hi-Bred on Kauai, failed inspections at their genetically modified corn plots. A consumer group charges that nearby corn crops - many of which are eventually exported around the globe  are in danger of contamination by unapproved, genetically modified pollen, placing public health at risk.

With Hawaii becoming one of the biotechnology worlds favourite spots to test new crops, any inkling of improper planting warrants an in-depth investigation of the hundreds of experimental crops there, said the Center for Science in the Public Interest, a Washington consumer health advocacy group.

"The danger is that the pollen from these crops could get out into the wild, into the environment, or into the food supply," said Gregory Jaffe, head of the Centers biotechnology project.

In recent years, companies including Pioneer, Monsanto and Dow have also increasingly used Hawaii as a spot to grow out "parent crops" of government-approved, genetically altered corn and other crops. These seeds are then distributed to farmers worldwide.

3. GM crops rejected worldwide

Zambia rejects GM food aid

The Zambian government decided to reject GM maize food aid after a protracted national debate over safety of the food, and environmental and socio-economic impacts. It was strongly supported by African countries, by aid agencies and ngos. The United States was widely condemned for using famine to blackmail poor countries to accept GM food and the risk of transgenic contamination.

Zimbabwe, Malawi and Mozambique have also expressed varying degrees of reservation to GM food aid over the past few months, despite a food shortage that threatens up to 13 million people in six countries of Southern Africa. They have now agreed to accept only milled GM grain.

The Zambian government has signed contracts with the private sector to bring in an additional 300,000 metric tons of non-GM maize to make up for the shortfall. An additional 156,000 tons of non-GM maize will also be imported as strategic reserves.

Zambia is struggling with a huge maize shortfall, brought on by drought and floods over the last two growing seasons.

Recently, a group of 8,000 small farmers protested the importation of GM maize from America, fearing the dislocation of the local farming systems and indigenous crop varieties.

Zambia is still looking to other sources of non-GM maize and financial resources to purchase the commodity. The World Food Programme (WFP) has bowed to protests and criticisms of its purchase of GM maize from the US, and has used cash donations from Japan and the Netherlands to purchase GM-free maize regionally. On 18 October, Reuters reported that the WFP has sent the 16,000 tonnes of GM-free maize to Zambia. The EU has also announced that it will provide southern Africa with humanitarian aid to the tune of 30 million euro ($29.57 million).

An estimated 12.8 million people in six southern Africa countries - Lesotho, Malawi, Mozambique, Swaziland, Zambia and Zimbabwe - will be in need of humanitarian food aid between now and next years harvest.

The Institute of Science in Society has earlier condemned GM food aid, calling for all food aid to the GM-free. "What is not safe for the rich and healthy is all the more so for the poor and sickly." Dr. Mae-Wan Ho, Director of ISIS said, "The starving and malnourished and others with compromised immune systems will be especially susceptible to the potential hazards of GM food."

USAID, in a bid to resolve the controversy, invited the Zambian government to visit the US. Keen to have a genuine fact-finding mission, a delegation of Zambian scientists, together with the Economic Adviser to the President, has just completed visits to the US, South Africa and Europe. The delegation has reported to the President, and a further announcement on the Zambian position on GM food aid is expected any moment.

The US and Canadian National Farmers Unions, American Corn Growers Association, Canadian Wheat Board, organic farming groups and more than 200 other groups are lobbying for a ban or moratorium on the next major GM food crop, GM wheat.

The Canadian Wheat Board reports that two-thirds of its customers do not want to buy GM wheat or even conventional wheat that could be contaminated with GM wheat, putting Canada's $4-billion international wheat trade at stake.

US Wheat Associates found in its survey of wheat buyers, millers and users that "there is currently an overwhelming rejection" of the Roundup Ready wheat plant Monsanto has developed.

According to another report, 100% of all representatives for Chinese, Korean and Japanese wheat buyers surveyed said they would not buy or use Roundup Ready wheat. The rejection rates in Taiwan and South Asia are 82% and 78% respectively. Japan, the largest buyer of US wheat this year, typically purchases about 3 million tonnes of US wheat annually, their buyers indicate that "regardless of government approval, contracts will stipulate no adventitious presence of GM wheat."

In August, Italy's biggest miller, Grandi Molini Italiani, said it would refuse to import GM wheat or any wheat from countries where GM wheat is grown. Italy has the largest milling industry in Europe.

Already, eight of the top 11 countries to which the US sells hard red spring wheat have regulations against GM wheat or labelling restrictions on GM foods that the US can't comply with.

Too many unanswered questions about contamination, The StarPhoenix, by Michelle Lang, 10 July 2002.

No Bt-cotton for Karnataka

The State Government of Karnataka has decided not to allow Bt-cotton to be grown as a commercial crop, till experts come up with a report on the adverse effects of the crop.

Speaking to journalists after a meeting with farmers representatives and Bangalore and Dharawad Agriculture University Vice-Chancellors 13 August, Agriculture Minister V S Koujalagi said the ban on the sale of Bt-Cotton would continue.

Farmers representatives have expressed their apprehensions about Bt-Cotton cultivation having an adverse effect on the health of human beings and animals. Officials explained the advantages and disadvantages of the Bt-Cotton crop. If the experts findings prove that Bt-Cotton is harmful, we will send a proposal to the Centre to ban Bt-Cotton, he added.

Research announced May 2002 showed that the vast majority of food and drink manufacturers say there is little chance of them making products containing GM ingredients for at least the next five years.

Seventy-per-cent of the 376 firms questioned said they either disagreed or disagreed strongly with any suggestion the market for GM food or drink in the UK would take off in the near future.

Rick Pendrous, editor of the trade magazine Food Monthly who conducted the survey, said: "Despite fears by leading industry figures about a possible trade war with the US unless Europe opens its markets to GM ingredients, those responsible for developing new food and drink products dont expect to be using them."

This is a blow to the Blair government, intent on forcing GM on British citizens after the controversial Farm Scale Evaluations (FSEs) of GM crops officially end next year. The FSEs have been forced onto local communities that voted overwhelmingly to reject them. Many trial sites have been destroyed in protest. Ordinary citizens continue to brave arrest and imprisonment in their fight for justice and democracy.

Landmark agreement in Australia to establish GM-free zones A landmark agreement in May 2002 between the commonwealth and states of Australia allows the establishment of GM-free agriculture zones.

A meeting of the Gene Technology Ministerial Council agreed to issue a policy principle allowing the states and territories to pass laws to establish zones in which genetically modified crops cannot be grown. Zones in which only GM crops can be grown can also be established.

The zones will allow producers to market produce labelled GM-free or organic knowing their crops have not been contaminated by GM-crops nearby, a spokeswoman for the council said yesterday.

Both South Australia and Victoria have established legislation to create the zones, and all other state and territory governments are committed to following suit.

Tasmania has declared the entire state GM-free.

Federal Health Minister Kay Patterson said, "The councils primary aim is to ensure that all Australians benefit from a sound, world-class regulatory system which protects the health and safety of Australians and the Australian environment, while supporting our aspirations as a world leader in gene technology research and application."

The Gene Technology Grains Committee, comprising more than 40 industry and government representatives, is developing a supply chain plan for the marketing of GM canola with a strong focus on segregating it from non-GM varieties.

The Tasmanian Greens credited their efforts towards keeping their island GM-free as a key reason for the record level of support they received at the state election.

The Greens surpassed even their own expectations to gain 18.2 percent of the total vote on Saturday, compared with 8 percent at the 1998 state poll.

State leader Peg Putt believed the result carried significance for the New Zealand general election.

New Zealands Greens say they will withdraw support from a Labour-led coalition government if a moratorium on field trials of GM-crops is not extended when the deadline expires in 18 months.

The Tasmanian result means the Greens representation in the states 25-seat lower house will rise from one MP to four. That puts them almost on a par with the Liberals, whose numbers will drop from 10 to five, leading Labour Premier Jim Bacon to comment that he now faces two opposition parties.

Federal Greens leader Bob Brown said the percentage of the vote won in Tasmania was the highest by a Green Party in any state or national election in the world, surpassing a recent result in Luxembourg.

Source:

"GE-free issue was a winner for Tasmania, says greens" New Zealand Press Association 22 July 2002.

West Australian bee-keepers reject GM

The beekeeping industry in West Australia has weighed into the GM debate. Delegates to the WA Farmers Federation annual conference in Perth voted to oppose the introduction of GM crops in WA.

The conference passed a motion that opposed the growing of GM crops in WA. The motion is to be taken to the WA Farmers general council meeting later in July and the GMO forum in May 2003.

WA Farmers delegates were joined by other sections of the WA beekeeping industry this week in united opposition to the introduction of GM crops.

Eduard Planken, CEO of WA apiarist-owned honey company Wescobee, was cited as saying that as far as he could tell, the consensus across the WA industry was the State should remain a GM-free zone.

Mr Planken said the beekeeeping industry would be the first of WAs agricultural industries hit if GM crops were introduced because the sensitivity to GM foodstuffs already was an issue for apiarists.
Source: "Beekeeper vote to oppose GM crops" by Paul Jarvis, The West Australian 25 July 2002.

Australian farmers want GM canola postponed

Australias largest farmers body called for the introduction of GM canola to be postponed until identity preservation issues were resolved.

The New South Wales Farmers Associations annual conference passed a motion calling for the postponement. The motion replaced an even tougher motion, which would have put a four-year moratorium on the general release of GM canola.

The motion was passed after lengthy debate which showed that Australian farmers still have great misgivings about introducing GM canola.

Australia produces between 1.5 and 2.0 million tonnes of canola a year, which competes against mainly Canadian canola on world export markets, particularly in Asia.

Australian canola is entirely non-GM, while Canadian canola is mainly GM. Australias first commercial GM canola crop was to be introduced next year, although final approval has not been granted by regulators.

Australian farmers believe that Australia's conventionally produced canola carries a market premium, with GM canola not accepted by consumers in some markets, primarily Europe.

Farmers in northern Victoria are calling for a three-year moratorium on the release of GM crops. The Kerang members of the Victorian Farmers Federation argued for the moratorium at the general council meeting. The move echoes the sentiments of a group of Kyabram dairy farmers who earlier tried to push the same motion at a United Dairyfarmers of Victoria district council meeting. The motion did not get up because of time restrictions, but the farmers vowed to write to individual UDV central councillors to ensure the issue was discussed at a central council meeting.

New Zealands new government fought the last election on GM, and is now banning imports of GM seeds. Australian seed giant Pacific Seeds had to incinerate 30 tonnes of maize in Auckland, New Zealand, after it emerged that the seed was contaminated with genetically modified material.

The GM material, designed to ensure insect and weed resistance, was discovered after routine post harvest testing. Tests are now underway to discover the source of contamination.

GM crops are banned in NZ, and the countrys new Ministry of Agriculture has reassured consumers that the affected corn seed has not entered the food chain.

However, 19 GM foods have been formally approved and can be present in non-viable form (eg in processed foods).

Living GM organisms must be assessed and approved before they can be released into the environment, though no GM organisms have been approved yet.

The planting of GM seeds is prohibited in Italy. The investigation follows tests carried out by state-owned seeds agency Ense (Milan). The court declined to identify the companies, but sources say that five are Italian and the rest are multinationals, including Monsanto and Pioneer Hi-Bred, a subsidiary of DuPont.

Source:

"Italy Launches GM Seed Probe", Chemical Week August 14, 2002

Hawaiian coffee growers urge delay of GM coffee

The Kona Coffee Council has called on the Hawaii Department of Agriculture, the University of Hawaii and all members of the Hawaii Coffee Association to impose a moratorium on any GM stock entering the Kona region. "We cannot be put in the same position our papaya farmers are in, where it is impossible to find papaya seed uncontaminated by the genetically modified strain," said Merle Wood, past president of the council. "The moment coffee becomes tainted with (genetically modified strains), then it won't sell as a premium gourmet coffee any-more, and that could put 650 Kona farmers out of business," said Christine Shepherd, current president of the coffee council.

On June 8, the Organic Consumers Association, Greenpeace, and the Genetic Engineering Action Network carried out coordinated protests in over 100 cities against US supermarkets, such as Shaws, Safeway, Food Emporium, Food Lion, Publix, and Albertsons to remove all GM ingredients from their brand name products. Three major natural food supermarkets, Whole Foods, Wild Oats, and Trader Joes, with combined sales of over five billion dollars, have already responded to consumer pressure and gone GM-free for their house brands, while even larger chains such as Shaws and Safeway are coming under grassroots pressure to do the same. An even larger GM-Free Markets national mobilization is planned for several hundred US cities the week of October 30.

BioDemocracy News 40: The Death of Frankenfoods, August 2002, by Ronnie
Cummins, Organic Consumers Association www.organicconsumers.org

4. Biosafety regulations tighten worldwide

More than 35 countries have laws in place or planned which require the mandatory labelling of food containing GM ingredients, or else laws restricting the import of some gene-foods. These countries comprise more than half the world s population.

Recently, Europe has opted for the strictest rules on traceability and labelling, and the signs are that the United States is giving ground and following suit.

Europe tightens rules for traceability & labelling of GMOs

The European Parliament adopted in its first reading on 3 July strict new rules on the labelling of food products and feed containing genetically modified organisms. Under the new rules, all GM food and feed products will have to be labelled and to be traceable irrespective of whether they contain GM DNA or protein. That means products such as sugar and highly refined oils produced from GMOs will also have to be labelled.

The new rules should establish the same requirements both for producers within and outside the EU. The Parliament has demanded a stricter threshold for labelling foods or feeds contaminated with GMOs. The Commission had proposed a 1 per cent threshold, but the Parliament demanded that this threshold be 0.5 per cent. The Parliament also rejected a proposal that GM foods that have not been yet approved in the EU should be allowed into human and animal food up to a level of 1%, so there should be no contamination by unapproved GM foods.

However, the MEPs turned down amendments (by 3 votes, 258 to 255) by the Greens that eggs, meat and milk from animals fed with GM feed should be labelled. A proposal calling for a GMO-free label, backed by the industry, was also rejected.

Europes council of agricultural ministers and environment ministers met in October, but both failed to reach agreement. The EU remains divided on the level of accidental GM content that should be allowed in a conventional product or shipment before labelling rules would kick in. In addition, some states are calling for meat and eggs from animals fed on GM feed to be labelled. The US is now grudgingly backing the Commission's proposal for a 1 per cent threshold. The European parliament, which shares decision-making power on the issue, wants 0.5 per cent.

GM crops will be kept out of Europe, despite new legislation designed to free up approvals. One reason, was given by ISIS a year ago ("Europes new rules could sink all GMOs" ISIS News 2001, 11/12, p.4-5)

The new Directive, which came into effect on 17 October, requires a full environmental risk assessment before any GM release. It also demands full consultation with all interested parties and compulsory monitoring during the trials and post-release stages. And any license will only be granted for an initial 10-year period.

The Directive actually requires much more, especially event-specific molecular data for unique identification of the GM line, which also prove that the line is genetically uniform and stable. Such data simply do not exist. Regulators must now insist on this data as a matter of routine.

The other reason is that there is still a moratorium in place, and lifting it depends on the EU environment ministers approving supplementary legislation on the labelling and traceability of GM crops. But agreement is a long way off, with a hard core of member states, led by France, wanting a lower threshold. They also want labelling to apply to processed foods in which GM traces have been destroyed, and to animal products such as eggs and milk.

Environmental campaigners point out that even with tough labelling, major problems such as liability, seed purity and the co-existence of GM and non-GM crops need to be resolved before the moratorium is lifted.

The USA is growing increasingly frustrated with the block on exports of a large proportion of its soya and maize crops. A US trade representative insisted the ban was illegal. He called for "an immediate, unconditional and unambiguous statement that the biotech approvals process is restarting now".

A moratorium has been in place since June 1999, effectively creating a GM-free zone in the EU.

Only a small amount of GM maize is currently grown, which was approved before the moratorium took hold.

Japan, one of the worlds biggest grain importers, is set to tighten regulations on GMOs, with plans to ban the import and sale of unapproved biotech crops for use in livestock feed. Currently Japan's Agriculture Ministry asks GMO suppliers to voluntarily undergo safety assessments. But faced with criticism of lax regulations, the ministry plans to make the assessment mandatory next April.

Under the new regulations, the ministry will test samples from grain cargoes to weed out unapproved GM varieties. The Agriculture Ministry's move follows similar steps taken last year by Japan's Health Ministry, the food safety authority, which has banned imports of foods containing unapproved GMOs.

But unlike the Health Ministry, which has adopted a zero tolerance policy on imports of unapproved GMOs, the Agriculture Ministry is considering allowing up to one percent of unapproved GMOs in feed grains. The rule will only be applied, however, to unapproved GMO varieties whose safety has already been confirmed by the originating country under testing standards set by the OECD.

New Zealand is introducing a tough new testing regime aimed at keeping GM crops out of the country. It will test all shipments of imported sweet corn, maize, canola and soybean seeds to ensure they contain no trace of transgenic DNA.

"If the testing shows any contamination at all, then the seeds will be rejected," Director of Plants Biosecurity, Richard Ivess, said.

A row over GM dominated the general election campaign in July, with the governing Labor party was accused of covering up the presence of modified corn on New Zealand farms.

Prime Minister Helen Clark, who won in the poll, rejected as "vile" claims of a cover-up made by Green Party campaigners. Clark said the nations Green Party had "ruled itself out" of a role in government by its threat to pull down any government that ends a nationwide moratorium on the release of GM plants and animals for commercial use in October 2003.

In the past year, only one 2.7 kilogram (5.9 pound) shipment of sweet-corn seed, from the United States, was found to contain genetically engineered DNA and was incinerated.

New Zealands farmers import 186 tonnes of maize and sweet-corn seeds each year, of which 161 tonnes come from the U.S.

The National Confederation of Farmers (NCF), one of Mexico's leading associations of small farmers, has submitted a draft bill to their nation's Congress that aims to segregate imported GM maize. In addition, the proposal includes provisions to: 1) transport GM maize separately from non-GM shipments; 2) thoroughly clean and inspect all storage areas and vehicles used for GM maize; and 3) monitor all shipments of GM maize to ensure that it is used for the purpose indicated on official documentation. NCF leaders say the costly procedures outlined in the bill are justified because they would prevent future incidents such as the one that occurred in Oaxaca, where illegal GM maize plantings may have cross-pollinated with native landrace species.

Amid growing global demand for non-GM food, the US Department of Agriculture (USDA) said it may create a voluntary system to verify if shipments of US corn, soya beans and other crops are GM.

"Commodity segregation to meet various customer needs is becoming essential to capture markets and value," the USDA said.

Under the planned programme, companies could choose to detail to the USDA how they keep their products separate from GM at every stage of the food chain. Federal inspectors would ensure that due handling and processing are followed.

This is welcome news for the American Corn Growers Association, and a step in the right direction, said spokesperson for the ACGA, Dan McGuire. US lost export sales of non-GM corn to China, which is selling 107,000 metric tons to South Korea.

This is US version of Europes labelling and traceability programme, and may be a sign that US is caving in to Europes tough stance over GM imports.

"It is now essential that any new USDA traceability program and the subsequent rules acknowledge the fact that conventional corn varieties represent the vast majority of the U.S. corn crop. Demand for conventional non-GMO varieties should not be described as a niche market." Says Dan McGuire.

Sources:

"US may set guidelines for biotech-free crops", by Randy Fabi, Reuter, 6 August 2002.

The White House, worried that unapproved GM crops will leak into the food supply, is proposing new safety reviews to better protect consumers and avoid the need for massive recalls, as happened with Starlink.

The proposed new rules are prompted by the many field trials of experimental GM crops going on in the country, that have not been approved for commercial release or human consumption, so even low levels of contamination may raise health concerns and food recalls.

So The White House Office of Science and Technology Policy is suggesting that crops undergo a preliminary safety assessment by the Food and Drug Administration or the Environmental Protection Agency before field trials grow large enough for contamination to take place. The assessment would look at the new protein introduced to see whether it is toxic or allergenic.

Andrew Kimbrell, director of the Center for Food Safety said the proposal was a step in the right direction, but was "too little too late". He wants a moratorium on all field trials. Gene Grabowski, spokesperson for the Grocery Manufacturers of America, said food companied would have preferred the safety assessment to be made mandatory.

Source:

"Earlier safety reviews proposed for gene-altered crops", by Andrew Pollack, New York Times, 2 August 2002.

US Federal District court bans GM salmon

US Federal District court in Maine approved a settlement on July 29 that prohibits a major factory fish farm, Heritage Salmon, from bringing its GM salmon onto the market. The Maine ruling, resulting from a lawsuit filed by the US Public Interest Research Group (USPIRG) and the National Environmental Law Center, sets an important legal precedent that threatens to block any future commercialization of GM fish--until now the second most important biotech blockbuster being readied for market.

BioDemocracy News 40: The Death of Frankenfoods, August 2002, by Ronnie
Cummins, Organic Consumers Association www.organicconsumers.org

Vast majority of US consumers support GM labellingMajor polls conducted last year by Rutgers University and ABC News both found that 90% of American consumers support GM labels. Even in Texas, Bushs home turf, a 2001 poll carried out by Texas A&M University found that 90% of Texans want mandatory labeling, and that 60% strongly supported labels.

On July 23, Oregons Secretary of State announced that a ballot initiative organized by anti-biotech activists, Oregon Concerned Citizens for Safe Foods,www.labelgefoods.org has successfully gathered almost 100,000 signatures from the state's 3.3 million residents-more than enough to place GM labelling on the ballot November 5.
Source: BioDemocracy News 40: The Death of Frankenfoods, August 2002, by Ronnie
Cummins, Organic Consumers Association www.organicconsumers.org